Holly Webb
Raleigh,NC
Summary
Versatile clinical research professional knowledgeable about coordinating trial information, project management and compliance documents for diverse clinical trials. Highly organized and thorough with good planning and problem-solving abilities. Certified in GCP(Good Clinical Practices).
Overview
2
2
years of professional experience
1
1
Certification
Work History
Clinical Trial Assistant
IQVIA
Durham, NC
07.2019 - 05.2020
- As Lead CTA on one study and CTA on two studies across US/Canada by creating plans to reach target deadlines and proactively raise any potential issues that could affect project timeline
- Accountable for delivery of assigned TMF activities in accordance with project timelines and requirements from Start-Up to Close-Out
- Conduct intensive and comprehensive review of TMF in compliance with IQVIA and/or customer file management plans and SOPs; then, facilitate collection and processing of documents to ensure inspection readiness
- Perform study-level and site-level submission to central IRBs and monitor site compliance for sites utilizing local IRBs
- Act as central point for clinical team as well as sites from project communications
- Assist project team in shipping and tracking of site ISFs, Study Reference Manuals, and other site supplies
- Provide training to both incoming and existing CTAs on, but not limited to: CTMS, regulatory documents file review process, sponsor-specific eTMFs, and general troubleshooting guidance
- Central Monitoring for USOR Sites
- Writing Monitoring Visit Reports(Confirmation Letters, Follow Up Letters,Site Visit Reports)
- Remote Monitoring of ISF Binder
- CTMS tracking of IRB Submissions and Approvals Progress
- Sponsor-specific TMFs
- Coordinated clinical trials focused on disorders such as Phase 4 Prostate Cancer and Phase 2 MS.
- Collected data and followed research protocols, operations manuals and case report form requirements.
- Followed informed consent processes and maintained records.
- Collected, evaluated and modeled collected data.
- Maintained compliance with protocols covering patient care and clinical trial operations.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets.
- Gathered, processed and shipped lab specimens.
- Resolved conflicts and negotiated mutually beneficial agreements between parties.
- Devoted special emphasis to punctuality and worked to maintain outstanding attendance record, consistently arriving to work ready to start immediately.
Clinical Trial Associate
Clinipace
Morrisville, NC
11.2018 - 07.2019
- As Lead CTA on one study and CTA on two studies across US/Canada by creating plans to reach target deadlines and proactively raise any potential issues that could affect project timeline• Supports and works closely with global project teams including internal and external customers and suppliers throughout all phases of a study.
- Participates in internal and client meetings, taking minutes and giving site management services updates.
- Distribution, collection, and review of all essential regulatory documents.
- Complete periodic audits of eTMF to confirm all documents are filed appropriately.
- Communicates study and site statues with study teams and clients.
- Review site level ICFs and support language negotiations between site and sponsor.
- Manage IRB submissions and continuing reviews.
- Assists in tfinalization of TMF review and close reconciliation.
- Assists in development of study plans and ensure all team training is documented.
- Distribute and track expedited safety reports.
- Track subject visits and site payments within CTMS.
- Produces, stores, and ships study supplies as needed including but not limited to EDB, subject questionnaires, and supporting study documents.
- Assist with training of newly hired clinical trial associates.
- Strong knowledge of Clinical Operations and CTA role with capacity to train and mentor fellow CTAs.
- Supports and works closely with global project team including internal and external customers and suppliers through all phases of study.
- Coordination and participation in study meetings, binder creation oversight, tracking, scanning, copying and creating, collecting, maintaining and QC of essential documents and Trial Master Files.
- Meets defined chargeability expectations for position
- Maintained compliance with protocols covering patient care and clinical trial operations.
- Collected, evaluated and modeled collected data.
- Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets.
- Followed informed consent processes and maintained records.
- Collected data and followed research protocols, operations manuals and case report form requirements.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Coordinated clinical trials focused on disorders such as Phase 3 Neurology and Phase 2 Gastroenterology.
- Resolved conflicts and negotiated mutually beneficial agreements between parties.
- Devoted special emphasis to punctuality and worked to maintain outstanding attendance record, consistently arriving to work ready to start immediately.
Wellness Specialist
Vidant Medical Center
Greenville, NC
08.2018 - 11.2018
- Assists with health assessments and health screenings for Vidant Employees and community members
- Collecting measures of height, weight, BMI, cholesterol levels, glucose levels, triglyceride levels, etc
- Educating clients about their results and progress during behavior changes
- Promoting healthy lifestyle choices through public speaking opportunities and booths at health fairs and classes
- Assists with scanning patients' medical charts and data entry into EPIC and Microsoft Office Applications.
- Built strong relationships with members to promote health, wellness and available services.
- Helped clients set and achieve health and wellness goals.
- Provided individual health coaching to help clients optimize personal choices.
- Monitored, tracked and reported on individual progress with wellness plans.
- Demonstrated safe and correct forms for each exercise and piece of equipment.
- Monitored social media and online sources for industry trends.
Health Education Intern
WakeMed
Raleigh, NC
01.2018 - 05.2018
- Assisted with Biometric Screenings-includes cholesterol, blood pressure, BMI and A1C tests on clients, WakeMed employees, and corporate partners
- Assisted with scanning patients' medical charts and data entry into EPIC and Microsoft Office Applications
- Created health educational handouts for WakeMed to use includes bone health, fiber intake, and nutrition
- Shadowed nutrition consultations with corporate clients to improve their health status
- Promoted healthy lifestyle choices through interactive demonstrations and booths at health fairs and classes.
Education
BACHELOR OF SCIENCE - Public Health Studies
EAST CAROLINA UNIVERSITY
Greenville,NC05.2018
Skills
- Project Management
- CTA Lead for Oncology Study
- Time Management
- Strategic Planning
- Good Clinical Practices
- Communication
- Problem Solving
- Health Coaching
- Public Speaking
- Leadership
- CTMS
- ELVIS
- WingSpan
- APEX
- WIRB/CGIRB
- Florence
- Lotus Notes
- Tempo
- Microsoft Office Applications
- Coaching
- Negotiations
- Clients, Problem Solving
- Client, Progress
- Delivery, Public Speaking
- File management, Safety
- Letters, Shipping
- Strategic Planning
- Meetings, Time Management
- Mentor, Troubleshooting
- Study protocols
- Research SOPs understanding
- Informed consent
- Project organization
- Team management
- Regulatory Compliance
- Customer service
- Relationship development
- Supervision
Certification
- GCP
- CHES
- BLS CERTIFICATION
Timeline
Clinical Trial Assistant
IQVIA
07.2019 - 05.2020
Clinical Trial Associate
Clinipace
11.2018 - 07.2019
Wellness Specialist
Vidant Medical Center
08.2018 - 11.2018
Health Education Intern
WakeMed
01.2018 - 05.2018
BACHELOR OF SCIENCE - Public Health Studies
EAST CAROLINA UNIVERSITY
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